“Women’s Health Protection Act” – HB 16-1203

** Basis for the testimony of Tom Perille, MD, before the Colorado House Health, Insurance and Environment Committee on April 7, 2016

Introduction

The Women’s Health Protection Act is an attempt to ensure that women who choose abortion are not victimized by those who would profit from the procedure. For pro-choice activists who for decades have railed against the prospect of unsafe/back-alley abortions, ensuring safe, sanitary conditions for this surgical procedure should be a no-brainer. Pro-life activists, who abhor abortion for its effects on the woman as well as the developing human, gain no solace from the maiming and mutilation of young women during a legal abortion procedure. Everyone in Colorado, regardless of their position on abortion, should endorse sound abortion clinic regulations, commensurate with the risk attributable to abortion.

The State of Colorado through the Department of Health and the Environment, Health Facilities and Emergency Medical Services Division, have promulgated rules concerning a wide variety of health care facilities to ensure public safety. They currently license hospitals, long term care facilities, acute treatment units, assisted living residencies, community clinics, rehabilitation centers, convalescent centers, chiropractic centers, birth centers, maternity hospitals, dialysis centers, psychiatric hospitals, ambulatory surgical centers, hospices and home care agencies.1 Abortion is the most common out-patient surgical procedure in the state and abortion clinics deserve to be included in this list of health care facilities with specific state oversight and supervision.

Mortality

The reason abortion clinic regulations are necessary is because abortion is a procedure with significant morbidity and mortality. The precise magnitude of the risk associated with abortion is not easy to glean from authoritative sources such as the Centers for Disease Control (CDC) since reporting abortion related complications/mortality is not federally mandated. Reporting is voluntary and not all states report to the CDC. States that do require reporting have varying mechanisms or sometimes no mechanism for enforcement. They lack standardized reporting forms. Furthermore, because the system is voluntary and physicians are reluctant to disclose serious complications (including death), underreporting is a major problem.2 (Colorado requires minimal abortion related reporting and has no enforcement mechanism). Consequently, it is hard to be sure of the exact number of abortions much less the associated morbidity and mortality. The CDC (and the Colorado Department of Health) readily acknowledges that their data are incomplete.3 Many pundits rely on information from the Guttmacher Institute which is considered more “authoritative”. The Guttmacher Institute started in 1968 as a semi-autonomous division of Planned Parenthood and is named after a former president of Planned Parenthood.4 They are an advocacy group which has a vested interest in minimizing the reported morbidity and mortality of abortion procedures. Consequently, to obtain the best information, one needs to look at other independent sources.

Researchers from the CDC have attempted to compensate for the inadequacies of their Pregnancy Mortality Surveillance System to better ascertain abortion mortality. They augment these data by using media reports, reports by public health agencies, state-based maternal mortality review committees, professional organizations, health care providers and individuals.5 By using this methodology they derive an overall mortality rate of 0.7 deaths per 100,000 abortion procedures. However, the rate of death is only 0.3 deaths per 100,000 for gestations <8 weeks but as high as 7.4 per 100,000 for gestations ≥ 18 weeks. Another earlier CDC analysis of abortion surveillance data reinforced the notion that the statistics vary dramatically by gestational age with 0.1 deaths per 100000 at ≤ 8 weeks, 1.7 deaths per 100,000 at 13-15 weeks, 3.4 deaths per 100,000 at 16-20 weeks and 8.9 deaths per 100,000 at > 21 weeks.6

The best way to overcome the deficiencies inherent in the US/CDC Pregnancy Mortality Surveillance System data is to look at states or countries which link comprehensive health and mortality databases using unique patient identification numbers such as Denmark.9 In Denmark, the risk of death within 180 days of early (<12 weeks) abortion is 19.0 per 100,000 women compared to 55.0 per 100,000 following late (>12 weeks) abortion and 7.8 per 100,000 for live birth. Linked databases from Finland and the California Medicaid system show similar findings.8 This suggests that the mortality in the second and third trimester may be significantly higher than the mortality associated with childbirth (8-10/100000). Those who have suggested that abortion is safer than childbirth utilize incomplete CDC/Guttmacher data that does not stratify risk based on gestational age.7 As many researchers have concluded, “inaccurate (abortion surveillance) data will produce inaccurate conclusions.8

Morbidity

Understanding the morbidity associated with abortion is fraught with similar problems of underreporting. Since there is not a reliable national database, one is forced to look at clinical trials for answers. Just as in the risk of mortality, the morbidity of abortion varies with gestational age. There are very few contemporary randomized trials of first trimester surgical abortions and one is forced to look at the less reliable retrospective trials and systematic reviews.10 Anywhere from <0.1% to 8.0% of first trimester abortions require repeat aspiration, primarily for retained products of conception. Between 0 and 4.7% of first trimester abortions require intervention or transfusion for excessive bleeding. Between 0 and 11.6% of first trimester abortions involved infections requiring antibiotic therapy. Uterine perforations in which additional emergent interventions were required occurred in ≤0.1% to 2.3% of first trimester abortions. Hospitalization was necessary for complications in 0 to 2.4% of first trimester abortions. A large retrospective study of surgical first trimester abortions from the University of Colorado found a similar overall complication rate of 2.9%.11

A systematic review of first trimester medical (mifepristone) abortions found minor side effects (nausea, vomiting, diarrhea, weakness, headache, fever and dizziness) were common.12 On the other hand, 3.3% of medical abortions failed (necessitating aspiration/evacuation) and there was a 0.8% rate of continuing pregnancy. With medical abortion, between 0.03 and 0.6% required transfusion and between 0.04 to 0.9% required hospitalization.

A large retrospective study of second trimester abortion points to substantially higher morbidity as gestational age increases.13 Significant complications occurred in 9.8% of second trimester abortions and major complications occurred in 1.7%. The most common complications were clinical hemorrhage (6.6%), uterine atony (3.0%), and hemorrhage with an estimated blood loss of 500 ml or greater (2.3%). Hospitalization was required in 1.6% of these second trimester abortions.

Other Out-patient Surgical Procedures

To put abortion associated morbidity and mortality in perspective, it is useful to look at the morbidity and mortality of other commonly performed out-patient surgical procedures. The data suggests that second and third term abortions pose a risk to women that is as high or higher than the most common out-patient surgical procedures performed in ambulatory surgical centers.14-19

The American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) compiled a 5 ½ year database of over 1 million out-patient surgeries performed in ambulatory surgery centers.14 Most of the surgeries were cosmetic or plastic surgeries. They report a 30-day mortality of 2/100,000. This is in the same range as first trimester abortions but much lower than 2nd/3rd trimester abortions. The Canadian counterpart, the Canadian Association for Accreditation of Ambulatory Surgical Centers (CAAASF), compiled morbidity and mortality data on all out-patient surgeries in their ambulatory surgical centers in 2010.15 Surgeries included plastic surgery procedures, bariatric surgeries, orthopedic surgeries, oral/maxillofacial surgery and urological surgeries. There were no fatalities and only 0.007% major complications.

Some of the highest risk out-patient surgical procedures include lumbar discectomy (herniated disc neurosurgery) with a complication rate of 3.5% and mortality of 60/100000,16 laparoscopic appendectomy with a complication rate of 6.7% and 0% mortality,17 laparoscopic inguinal hernia repair with complication rate of 1% and mortality of 20/10000018 and laparoscopic cholecystectomy (gallbladder) with a complication rate of 3.7% and mortality of 200/100000.19 Again, these demonstrate risks in the same range as second and third term abortions which are commonly performed in clinics without the benefit of the safety/quality ensured by accredited ambulatory surgical centers.

Out-patient Surgery in Offices/Clinics vs. Ambulatory Surgery Centers

There is virtually no good data comparing the outcomes of out-patient surgery performed in offices/clinics vs ambulatory surgical centers. One study found a 10-fold increase in adverse incidents and death in office surgical procedures compared to surgical procedures performed in ambulatory surgery centers.20 This finding has been questioned by others.21 Looking at a large Medicare database, another study found a 25% reduction in complications and death when out-patient surgical procedures were performed in ambulatory surgery centers compared to offices.22 Suffice it to say that accredited ambulatory surgical centers have surgical suites designed for specific high volume procedures, improved technology/equipment, improved staff qualifications and safety protocols that make them a better choice for out-patient surgical procedures that are associated with well-defined morbidity/mortality.

Current State of Abortion Facility Oversight

Because of the contentious nature of abortion services in the United States, dispassionate objective state oversight of abortion facilities commensurate with the risk associated with these procedures has been the exception rather than the rule. Politics has often trumped evidence based medical care.

The failure of state oversight is best illustrated by the case of Kermit Gosnell in Pennsylvania. The Grand Jury investigating the abuses at Gosnell’s “Women’s Medical Society” location in Philadelphia describe a “house of horrors” that speaks for itself. Below are excerpts from the Grand Jury report23:

“This case is about a doctor who killed babies and endangered women. What we mean is that he regularly and illegally delivered live, viable, babies in the third trimester of pregnancy – and then murdered these newborns by severing their spinal cords with scissors. The medical practice by which he carried out this business was a filthy fraud in which he overdosed his patients with dangerous drugs, spread venereal disease among them with infected instruments, perforated their wombs and bowels – and, on at least two occasions, caused their deaths. Over the years, many people came to know that something was going on here. But no one put a stop to it. Let us say right up front that we realize this case will be used by those on both sides of the abortion debate. We ourselves cover a spectrum of personal beliefs about the morality of abortion. For us as a criminal grand jury, however, the case is not about that controversy; it is about disregard of the law and disdain for the lives and health of mothers and infants. We find common ground in exposing what happened here, and in recommending measures to prevent anything like this from ever happening again.”

“Gosnell’s clinic – with its untrained staff, its unsanitary conditions and practices, its perilously lax anesthesia protocols, its willingness to perform late-term abortions for exorbitant amounts of cash, and its routine procedure of killing babies after they were delivered by their unconscious mothers – offers a telling example of how horrendous a Pennsylvania facility can be and still operate with Department of Health “approval.””

“Pennsylvania’s Abortion Control Act requires any doctor who treats a woman because of a complication arising from an abortion to make a report to the Department of Health. Willful failure to do so constitutes “unprofessional conduct” and subjects the treating doctor to sanctions by the Board of Medicine. Clearly, this law is being violated, if not willfully, at least consistently. …….We learned of at least five of Gosnell’s patients who were treated for serious complications at the Hospital of the University of Pennsylvania (HUP) or Presbyterian Hospital, the two closest emergency rooms to the Women’s Medical Society clinic. We heard evidence of many more women, whose names we did not learn, who also had to seek emergency care after undergoing abortions at Gosnell’s facility. Yet we received no complication reports when we subpoenaed documents from DOH.”

The Grand Jury concluded their report with a number of recommendations which included enhanced oversight of abortion clinics:

“Under the plain language of the Health Care Facilities Act, abortion clinics should be regulated, licensed, and monitored as Ambulatory Surgical Facilities(ASF). Had the state Department of Health not inexplicably declined to classify abortion clinics as ASFs, Gosnell’s clinic would have been subject to yearly inspection and licensing. The department’s inspectors could have inspected at any time, announced or unannounced, to investigate any complaints. The sight of unlicensed employees sedating

patients in Gosnell’s absence would presumably have triggered action. Given the clinic’s filthy conditions, it surely would have been shut down long ago if DOH had merely taken a look. The regulations for Pennsylvania’s ambulatory surgical facilities – which run over 30 pages – provide a comprehensive set of rules and procedures to assure overall quality of care at such facilities. The effect of the Department of Health’s reluctance to treat abortion clinics as ASFs was to accord patients of those facilities far less protection than patients seeking, for example, liposuction or a colonoscopy. Those clinics, unlike abortion facilities, must implement measures for infection control (28 Pa. Code. §567.3 lists 17 specific procedures that ASFs must follow to control infection). They must use sterile linens (§567.21-24). They must keep premises and equipment clean and free of vermin, insects, rodents, and litter (§567.31). The regulations devote three pages to anesthesia protocols (28 Pa. Code §555.33). Gosnell’s facility fell far below the basic, minimum standards of care that any patient having a surgical procedure should expect to receive. There is no justification for denying abortion patients the protections available to every other patient of an ambulatory surgical facility, and no reason to exempt abortion clinics from meeting these standards.”

Pennsylvania subsequently passed a law to have abortion clinics meet the standards of ambulatory surgical facilities. As a result of the law, additional abortion clinics were inspected and found to be unsafe. Two abortion clinics operated by Dr. Soleiman Soli in Bensalem and Philadelphia were closed after inspectors found unsterilized equipment, a lack of required resuscitative equipment, and outdated medications from the 1970s and 1980s amongst other violations.24

Since 2010, and the publicity surrounding the Gosnell case, many other states have identified horrific conditions in abortion clinics. In Maryland, abortionist Stephen Brigham and Nicola Riley were arrested after a botched abortion resulted in a ruptured uterus at their Elkton abortion facility.25-27 (Dr. Brigham operated abortion clinics in Pennsylvania, New York, New Jersey, Maryland and Virginia which all have been accused of a litany of unsafe/unsanitary practices or closed).34 Thirty-five corpses of late term viable babies were discovered in the freezer. This incident instigated the Maryland legislature to pass new abortion facility regulations that took effect in July 2012. Since then the Maryland has suspended three abortion clinic licenses for health/safety violations including a clinic where a young woman with antecedent heart issues died from a first trimester abortion following inadequate attempts at resuscitation.

Two Delaware Planned Parenthood clinics were voluntarily closed in 2013 after allegations of malpractice by the staff abortionist, Dr. Timothy Liveright, and unsafe and unsanitary conditions at the clinics.28 After a history of abortion malfeasance and malpractice in Michigan, Dr. Timothy Roth’s lost his abortion clinic and was disciplined for performing abortions at client’s home.29 In 2011, a clinic in Rockford Illinois was temporarily closed after the Department of Health found there was a “direct threat to the public”.30 The clinic was permanently closed after they failed to take corrective action in January 2012. In 2013 an Ohio abortion clinic was closed because of gross violations of health and safety.31 Indiana revoked the license of a South Bend abortion clinic operated by Dr. George Klopfer in 2016.32 Dr. Klopfer had been accused of longstanding health/safety violations including improper anesthesia techniques, expired medications, under-trained staff, and unsanitary conditions at his three abortion clinics in Gary, Fort Wayne and South Bend spanning a period of years. Alabama closed a Birmingham abortion clinic in 2012 for a plethora of health and safety violations.33

To understand why so many abortionists would practice in such deplorable conditions and jeopardize the lives of young women, one can look to the cogent observations of Dr. LeRoy Carhart, the late term abortionist who is nationally recognized as a champion of abortion rights. He said “They have made it so the good physicians don’t really want to get involved….Now you have two types of doctors doing abortions –the doctors who are totally committed to women’s health and are going to do them even if they never get a dime, and the people that just want to take advantage of the situation and milk everything they can out of it.”34 Others have observed that these latter physicians “play fast and loose with laws.. so that their costs are less than those of other clinics that conform to other requirements…they typically prey on immigrant communities and they prey on poorer women.” It is because of this reality that oversight and regulation of abortion facilities should be every state’s imperative.

Recommendations

The Guttmacher Institute reports that Colorado had 42 abortion providers and 24 abortion clinics in 2011.35 There were 10,648 abortions performed in Colorado in 2014 and as many as 1411 were performed in the second or third trimester.36 Based on the risks inherent in abortion and the potential for abuse by unscrupulous providers, Colorado should take concrete steps to establish licensing and oversight requirements for abortion clinics. HB-16-1203 would accomplish this task since it promotes adherence to those standards already promulgated for ambulatory surgical centers for all abortion clinics. However, at a minimum new legislation should:

Set standards for the physical structural requirements for facilities performing second and third term abortions.

Set standards for clinic equipment and supplies in facilities performing second and third term abortions to ensure the ability of the clinic to initiate appropriate resuscitative efforts in the event of major/life threatening complications.

Set standards of training/credentialing for the staff employed in abortion facilities performing second and third term abortions.

Set standards for pre-operative medical screening and evaluation for abortion facilities performing second and third term abortions.

Set standards for safety, quality improvement and follow-up for abortion procedures in facilities performing second and third term abortions.

Set standards for the use of anesthesia and recovery room protocols in abortion facilities performing second and third term abortions.

Set legally binding standards for reporting complications and deaths arising from abortion procedures.

Set minimum annual inspection schedules for abortion clinics performing second and third term abortions.

Clinics performing second and third term abortions should have physicians credentialed by hospitals within 30 miles and/or have explicit transfer agreements with hospitals within 30 miles that ensure seamless transitions of patients/records after major complications.

Thomas J. Perille MD FACP FHM

Director, Protect Life Coalition

References

Colorado Secretary of State, Code of Colorado Regulations, Official Publication of the State Administrative Rules (24-4-103(11) C.R.S.)

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In Honor of Governor Robert Casey and Sargent & Eunice Shriver

In 1992, Robert Casey and Sargent and Eunice Shriver took out a full page ad in the New York Times outlining A New American Compact: Caring about Women, Caring for the Unborn. It spoke to the heart of the consistent life ethic and whole life principles we share as Pro-Life Democrats. The writers on this blog, a project of Democrats for Life of America, look to promote the best of the Democratic tradition, which is articulated so eloquently in this compact, for the respect and dignity for the whole person.